BACK MASSAGE APPLIED CLIMACTERIC WOMEN MENOPAUSAL COMPLAINTS, SLEEP QUALITY AND MARITAL ADJUSTMENT

Sponsor
Nuh Naci Yazgan University (Other)
Overall Status
Completed
CT.gov ID
NCT05298527
Collaborator
(none)
126
1
2
8
15.7

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the effect of back massage applied by partners on menopausal complaints, sleep quality, and marital adjustment of women in climacteric period.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Back Massage
N/A

Detailed Description

Climacterium is a life period in which women move from the reproductive age to the period when their reproductive ability is lost due to the decrease in ovarian functions. The most common climacteric disorder is vasomotor changes. The most common problem seen in menopausal period after vasomotor complaints is insomnia.

Sleep disorders seen in climacteric period negatively affect the quality of life and psychosocial health of woman. In their study, Jean-Louis et al., expressed that women in menopausal period spent approximately 10% of their daily sleep time by sleeping outside the bed during the day. 61% of menopausal women woke up at least once a week and several times from the night's sleep. In their study, Anttalainen et al., determined that women in postmenopausal period had more sleep problems compared to women in premenopausal period. In addition to physical changes due to hormonal changes in climacterium, mental problems such as nervousness, anxiety and depression developing in women may negatively affect the relationships in family environment especially the communication with the spouse. Besides, it is thought that an incompatible marriage can increase menopausal complaints. In the studies investigating the relationship between menopausal complaints and marital adjustment, women with compatible marital life were found to experience less menopausal complaints. Due to the negative effects of physician-controlled hormone replacement treatment administered to reduce menopausal symptoms, demand for non-pharmacological interventions has increased and women have started to accept that therapeutic massage is safe and contributes to health. It is stated that women experience insomnia, a symptom of menopause, and tend to choose especially body therapies from alternative therapies in the first place. Massage is widely accepted as a treatment tool. Although the menopausal period is physiological, it is a period that must be addressed specifically by healthcare professionals since it is accompanied by pathological events causing distress in life and impairing the quality of life.

The purpose of this study is to determine the effect of back massage applied by partners on menopausal complaints, sleep quality, and marital adjustment of women in climacteric period.

Study Design

Study Type:
Interventional
Actual Enrollment :
126 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The study was conducted as the randomized controlled experimental trial.The study was conducted as the randomized controlled experimental trial.
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
THE EFFECT OF BACK MASSAGE APPLIED BY PARTNERS TO CLIMACTERIC WOMEN WITH SLEEP PROBLEM ON MENOPAUSAL COMPLAINTS, SLEEP QUALITY AND MARITAL ADJUSTMENT
Actual Study Start Date :
May 1, 2016
Actual Primary Completion Date :
Jul 15, 2016
Actual Study Completion Date :
Jan 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention Group

In this study, the purpose of the study was explained to the women from intervention group and their partners by visiting them in their home. Personal Information Form (PIF), Pittsburgh Sleep Quality Index (PSQI), Menopause Symptoms Rating Scale (MSRS) and Marital Adjustment Scale (MAS) were filled by the women and MAS was filled by their partners. Firstly, back massage was taught to the partners of women in the intervention group. The massage was made half an hour before the women's sleep time for a total of 15 minutes. Partners were ensured to apply this massage twice a week for four weeks. The intervention group was called by telephone every week to ensure continuity of the study. By visiting those at their homes again at the end of the fourth week, PSQI, MSRS, and MAS were filled by the women and MAS was filled by their husbands for the last time.

Behavioral: Back Massage
The woman lies face down and a pillow is placed under her forehead. Massage begins with effleurage. Petrissage is started from the sacrum and the hands are lifted up to the nape and repeated 4 times. After the petrissage movement is completed, effusion is applied to the area once. Friction is applied. After rubbing, tapotement is applied to the entire back.

No Intervention: Control Group

In this study, the purpose of the study was explained to the women from control group and their partners by visiting them in their home. Their signatures indicating that they agreed to participate in the study were obtained after having them read the informed consent form. Personal Information Form (PIF), Pittsburgh Sleep Quality Index (PSQI), Menopause Symptoms Rating Scale (MSRS) and Marital Adjustment Scale (MAS) were filled by the women and MAS was filled by their partners. No application was made to the couples in the control group. By visiting those at their homes again at the end of the fourth week, PSQI, MSRS, and MAS were filled by the women and MAS was filled by their husbands for the last time. Back massage training was given to the partners of the women in the control group at the end of the fourth week.

Outcome Measures

Primary Outcome Measures

  1. Pittsburgh Sleep Quality Index (PSQI) [4 minutes]

    It is a scale developed by Buysse et al., in 1989. Its validity and reliability study was conducted in 1996 by Ağargün et al. PSQI provides a quantitative measure of sleep quality. There are 24 questions in the scale and 19 of these questions are self-rated. PSQI total score of 5 or higher indicates poor sleep quality. The Cronbach's alpha internal consistency coefficient of the scale, whose validity and reliability was conducted by Ağargün et al. was determined as 0.80.

  2. Menopause Symptoms Rating Scale (MSRS) [2 minutes]

    The Menopause Symptoms Rating Scale, originally called as Menopause Rating Scale, was developed in German by Schneider, Heinemann et al. in 1992 to determine the severity of menopausal symptoms and their effect on quality of life. The English adaptation, validity and reliability of the scale were conducted in 1996 by Schneider, Heinemann et al. The validity and reliability study of the scale was conducted in Turkey by Özlem Can Gürkan. The minimum score of the scale is "0" and the maximum score is "44". The high total score of the scale indicates that both quality of life is low and menopausal complaints are high. In the validity and reliability study by Gürkan, the Cronbach's alpha internal consistency coefficient was found as 0.84.

  3. Marital Adjustment Scale (MAS) [3 minutes]

    MAS, developed by Locke and Wallace in 1959, is composed of 15 items. The validity and reliability of the scale was conducted by Tutarel-Kışlak in 1999. It was found that the scale can significantly distinguish coupes with and without marital problems. The cut-off point of the scale is 43. While scores lower than 43 refer to a general marital maladjustment, scores higher than 43 indicate overall marital adjustment. In the validity and reliability study of Tutarel-Kışlak, the Cronbach's alpha internal consistency coefficient of the scale was found as 0.90.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • women aged between 40-65 years,

  • women who have 5 or more points from Pittsburgh Sleep Quality Index (PSQI),

  • women who do not use hormone therapy or who stopped hormone therapy at least one year ago.

Exclusion Criteria:
  • women who had sleep problems before climacteric period,

  • women who had uncontrolled chronic disease,

  • women receiving psychiatric treatment and/or using sleeping pills,

  • women with open wounds on their back were excluded from the study group.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nuh Naci Yazgan University Kayseri Kocasinan/Kayseri Turkey

Sponsors and Collaborators

  • Nuh Naci Yazgan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
DİDEM KAYA, Assistant Professor Doctor, Nuh Naci Yazgan University
ClinicalTrials.gov Identifier:
NCT05298527
Other Study ID Numbers:
  • NuhNaciYazganU
First Posted:
Mar 28, 2022
Last Update Posted:
Mar 28, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by DİDEM KAYA, Assistant Professor Doctor, Nuh Naci Yazgan University

Study Results

No Results Posted as of Mar 28, 2022